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Aesica Pharmaceuticals (Newcastle upon Tyne, UK), a supplier of active pharmaceutical ingredients, finished dosage forms, and custom-synthesis solutions, received approval from UK authorities to manufacture controlled substances at its Cramlington, United Kingdom, site.
Anavex Life Sciences (Geneva, Switzerland) announced the completion of scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease. The company said it will soon announce the selection of the contract research organization in charge of carrying out its Phase I clinical trials.
Bachem (Bubendorf, Switzerland), agreed to be the primary manufacturer of ImmuneRegen BioSciences (Scottsdale, AZ), a subsidiary of IR BioSciences Holdings, Homspera drug substance. Homspera is a peptide analog of the endogenous neurokinin Substance P, and is being developed by ImmuneRegen. In a separate announcement, Bachem announced the conclusion of a long-term cooperation with mondoBIOTECH (Stans, Switzerland). The announcement also stated that Bachem will provide peptide-based active ingredients required by mondoBIOTECH in future development projects, as well as sterile finished products to be used in clinical trials.
Boehringer Ingelheim (Ingelheim, Germany) entered into an agreement with Pfizer (New York) to acquire certain assets of Wyeth Pharmaceutical’s Fort Dodge Animal Health business upon the closing of the global Pfizer–Wyeth merger, which is expected to occur early in the fourth quarter. The deal, which is subject to regulatory approval, will significantly increase the size of Boehringer Ingelheim’s companion animal and cattle portfolios, according to a company press release.
Catalent Pharma Solutions (Somerset, NJ) and GlaxoSmithKline (GSK, London) have agreed to extend their contractual relationship under which Catalent will continue to supply GSK with its trade requirements of Lovaza omega-3 acid ethyl esters in soft-gelatin capsules. Lovaza is an omega-3 prescription medication derived from fish oil approved by the US Food and Drug Administration to reduce very high triglycerides. The Lovaza softgels are manufactured in Catalent’s St. Petersburg, Florida, facility, which is part of Catalent’s Oral Technologies segment.
DOR BioPharma (Princeton, NJ), a biotechnology company, was awarded an approximate $9.4 million grant from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health. The grant will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines that are stable at elevated temperatures. The grant will also fund the development of improved thermostable adjuvants, which the company expects will result in rapidly acting vaccines that can be given with fewer injections over shorter intervals, according to a press release.
Laureate Pharma (Princeton, NJ), a biopharmaceutical development and protein-production company, entered into a development and manufacturing agreement with ZZ Biotech (Rochester, NY). According to the agreement, Laureate will produce Activated Protein C variant under current good manufacturing practice conditions. Terms of the manufacturing agreement were not disclosed.
Johnson & Johnson (J&J, New Brunswick, NJ), through its subsidiary Ortho-McNeil-Janssen Pharmaceuticals, and Crucell (Leiden, The Netherlands) entered into a monoclonal antibodies (mAB) and vaccines collaboration, the immediate focus of which is the development and commercialization of a universal monoclonal antibody product (flu-mAb) for the treatment and prevention of influenza. Additionally, J&J, through its affiliate JHC Nederland B.V., purchased 14.6 million newly issued ordinary shares of Crucell, representing approximately 18% of Crucell's outstanding ordinary shares, for € 301.8 million.
Nycomed (Zurich, Switzerland) plans to build a new manufacturing plant near the city of Yaroslavl, Russia. The company plans to invest between €65 million ($95 million) to €75 million ($110 million). Construction starts in 2010, and the plant will start production in 2014 with approximately 150 employees. The facility is designed to manufacture liquid sterile products as well as solid-dosage products.
Royal Philips Electronics (Andover, MA) and Celsion (Columbia, MD) announced that their joint research program to evaluate ThermoDox in combination with magnetic-resonance-guided, high-intensity-focused ultrasound (MR-HIFU) as a combination therapy to noninvasively treat cancer has completed the feasibility stage. The program has now moved into preclinical development and will focus on the combined use of ThermoDox (Celsion's heat-activated liposomal drug) and Philips' MR-HIFU system for the treatment of pancreatic cancer and cancer metastases in bone. Philips' MR-HIFU system has the potential to precisely and noninvasively target lesions with acoustic energy, creating sufficient heat to activate ThermoDox and preferentially release high concentrations of the drug doxorubicin, according to a company press release.
RXi Pharmaceuticals (Worcester, MA), a biopharmaceutical company pursuing proprietary therapeutics based on RNA interference (RNAi), recently acquired direct ownership of technology for which it had previously exercised its option to exclusively license from Advirna (Boulder, CO). The acquired technologies potentially enable in vivo delivery of RNAi therapeutics. Terms of the agreement were not disclosed. The company decided to acquire ownership of the self-delivering rxRNA (sd-rxRNA) platform because the technology was successful in preclinical studies, according to a company press release.
Sandoz (Holzkirchen, Germany) completed its $1.3-billion acquisition of EBEWE Pharma's (Unterach, Austria) specialty generic injectables business. The transaction offers Sandoz a complementary portfolio of differentiated generics, with more than 15 marketed products and a strong pipeline with several near-term launches, according to a company press release.
Vetter (Ravensburg, Germany) announced that the Ravensburg Vetter South site was officially inaugurated on Sept. 25, 2009. Vetter has invested significantly into the site during the past six years, which features a total area of roughly 862,000 ft2, and includes facilities for the aseptic filling and packaging of injectable drugs.
Warner Chilcott (Ardee, Ireland) and LEO Pharma (Copenhagen) announced today that, in exchange for a one-time cash payment of $1 billion to Warner Chilcott, LEO Pharma is re-acquiring Warner Chilcott's exclusive product licensing rights in the United States to its topical psoriasis treatments Taclonex, Taclonex Scalp, Dovonex as well as rights to all products in LEO's development pipeline, and all inventories of the products.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
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The US Food and Drug Administration announced an amendment to its Aug. 26, 2009, Federal Register posting regarding the selection process and nominations for a nonvoting industry representative on the tobacco products scientific advisory committee. The revised date for sending a letter to the agency about participating in the selection process is Oct. 26, 2009. The address for sending a letter was also changed to: Teresa L. Hays, FDA, Center for Tobacco Products, 9200 Corporate Blvd, Rockville, MD 20850-3229, 301.796.3699, Teresa.Hays@fda.hhs.gov. Finally, the text in the original announcement regarding the selection process was modified.
In related tobacco-industry news, FDA is making candy and fruit-flavored cigarettes, including cloves, illegal in the United States. The ban is authorized by the new Family Smoking Prevention and Tobacco Control Act and is part of a national effort by FDA to reduce smoking in America, according to an agency release.
The European Medicines Agency (EMEA) intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into its centralized procedure within two years, according to a statement of intent from the agency. PIM implementation is currently in a pilot phase where PIM submissions are only accepted subject to prior discussion with the EMEA. The agency's statement, however, has outlined four main milestones that will lead to full implementation of PIM. Those milestones are available on the EMEA website.
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Amarillo Biosciences (Amarillo, TX) appointed Bernard Cohen as chief financial officer. Cohen replaces Gary Coy, who will assist the company with SEC filings as a consultant. Previously, Cohen was Director of Finance and Data Base Manager at Harrington Regional Medical Center in Amarillo, Texas.
Amsterdam Molecular Therapeutics (AMT, Amsterdam), a company focused on human gene therapy, appointed Jorn Aldag as its CEO, effective Oct. 5, 2009. Sander van Deventer will step down as interim-CEO of AMT. He will continue to contribute to the company as a scientific advisor.
Catalent Pharma Solutions (Somerset, NJ) appointed Will Downie in a dual role as group president of sterile technologies and senior vice-president of global sales and marketing, effective Oct. 12, 2009. Downie will report to John Chiminski, president and CEO of Catalent, and will be based in Catalent’s Swindon, United Kingdom, office.
Maxygen (Redwood City, CA) appointed James Sulat CEO, effective Oct. 1, 2009. Sulat, who currently serves as a director of the company, will replace Russell Howard, who has served as Maxygen’s CEO and as a director since June 1998. Howard will be leaving his positions as an officer and director on Sept. 30, 2009, as will Larry Briscoe, chief financial officer.
Pfizer (New York) announced the election of Frances D. Fergusson and John P. Mascotte to its board of directors. Fergusson and Mascotte, current members of the board of directors of Wyeth, will join the Pfizer board upon the closing of Pfizer’s pending acquisition of Wyeth in accordance with the terms of the merger agreement.
Tianyin Pharmaceutical (Chengdu, China), a manufacturer and supplier of modernized traditional Chinese medicine, appointed Tao Yang chief operating officer. Yang was appointed in November 2008 as chief advisor for sales and marketing and special advisor to the CEO of the company.
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